Cleared Traditional

PENTAX Medical Video Esophagoscope EE17-J10

K223072 · Pentax of America, Inc. · Ear, Nose, Throat

Dec 2022

Decision

63d

Days

Class 2

Risk

About This 510(k) Submission

K223072 is an FDA 510(k) clearance for the PENTAX Medical Video Esophagoscope EE17-J10, a Esophagoscope (flexible Or Rigid) (Class II — Special Controls, product code EOX), submitted by Pentax of America, Inc. (Montvale, US). The FDA issued a Cleared decision on December 2, 2022, 63 days after receiving the submission on September 30, 2022. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4710.

Submission Details

510(k) Number	K223072 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2022
Decision Date	December 02, 2022
Days to Decision	63 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	EOX — Esophagoscope (flexible Or Rigid)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4710
Definition	If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).